Testing was performed at abbott diagnostics (b)(4) inc.On retained kit lot 119305 with internal positive quality control samples and negative quality control swabs.All test results were valid and performed as expected.Additionally, the manufacturing records and quality control release testing was reviewed for test kit part number 7d2648 / lot 119305 and device part number 10732998 / lot 118361 the lot met the required release specifications.A review of the complaints reported as false positive patient results (confirmed and unconfirmed, conflicting results) related to kit lot 119305 showed that the complaint rate is (b)(4).Abbott diagnostics (b)(4) was unable to determine the exact root cause of the reported issue, however it could be attributed to the specific patient samples.
|